Stress urinary incontinence in women may be caused by urethral hypermobility. Hypermobility is a condition in which the pelvic floor fails to properly support an area between the bladder neck and mid-urethra, thus permitting the urethra to descend from its normal anatomic position in response to increases in intra-abdominal pressure, resulting in urinary incontinence.
Surgical procedures for stabilizing the urethra include suburethral slings and needle suspensions. In some sling procedures, a suburethral sling is placed around the posterior side of the urethra and the ends are attached to an anatomical support structure, for example, the Cooper's ligament, or the abdominal fascia. In some variations, however, a suburethral sling may be placed around the posterior side of the urethra with the ends left free, that is, the ends of the sling are not attached to an anatomical structure. In needle suspension methods, the urethra is suspended by fastening periurethral tissue to anatomical support structures using sutures. In one variation of both the suburethral sling and the needle suspension procedures, the sling or suture is attached to the pubic bone by a bone anchor or surgical staple. The introduction of such foreign objects into bone, however, presents a risk of bone marrow infection and/or pubic osteitis. Furthermore, drilling holes into the pubic bone and/or driving a bone anchor into the pubic bone is contraindicated for patients with osteoporosis. The common goal of suburethral sling and bladder neck suspension procedures is to return the poorly supported, hypermobile urethra to its normal retropubic position.
Suburethral sling procedures and needle suspension procedures involve cutting through vaginal and/or retropubic tissue using a sharp tunneling instrument such as a suspension needle or a suture carrier. Because suspension needles and suture carriers include a sharp tip, there is a danger that the needle or carrier may wound large blood vessels present in the operating regions. Sharp-tipped suspension needles and suture carriers also present a risk of puncturing or otherwise injuring the bladder and/or other abdominal organs. Furthermore, the sharp end of the suspension needle or the suture carrier may cause puncture wounds to the surgeon's fingers, thus presenting a potential risk of infection to both the patient and the surgeon.
Variations of suburethral sling and needle suspension procedures involve different approaches for accessing the surgical field. For example, some suburethral sling and needle suspension procedures involve open retropubic surgery, where the surgical field is accessed through an incision in the anterior abdominal wall followed by dissection with sharp instruments. Alternatively, the surgical field may be accessed through an incision in the anterior vaginal wall followed by dissection with sharp instruments. In some procedures, a combined abdominal and transvaginal approach is employed. Such procedures involving “blind” dissection with sharp instruments is highly invasive and may cause significant trauma to the patient.